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WO2021046120A1 - Gestion de tension de conformité pour un dispositif de stimulation - Google Patents

Gestion de tension de conformité pour un dispositif de stimulation Download PDF

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Publication number
WO2021046120A1
WO2021046120A1 PCT/US2020/049054 US2020049054W WO2021046120A1 WO 2021046120 A1 WO2021046120 A1 WO 2021046120A1 US 2020049054 W US2020049054 W US 2020049054W WO 2021046120 A1 WO2021046120 A1 WO 2021046120A1
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WO
WIPO (PCT)
Prior art keywords
compliance voltage
pulses
group
compliance
determined
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2020/049054
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English (en)
Inventor
G. Karl STEINKE
Adam T. FEATHERSTONE
Mary KOTCHEVAR
Emanuel Feldman
Goran N. Marnfeldt
Kenneth HERMANN
Chirag Shah
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Neuromodulation Corp
Original Assignee
Boston Scientific Neuromodulation Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Neuromodulation Corp filed Critical Boston Scientific Neuromodulation Corp
Priority to EP24197789.1A priority Critical patent/EP4464366A3/fr
Priority to EP20772176.2A priority patent/EP3993867B1/fr
Priority to US17/753,135 priority patent/US12383745B2/en
Priority to AU2020340952A priority patent/AU2020340952B2/en
Publication of WO2021046120A1 publication Critical patent/WO2021046120A1/fr
Anticipated expiration legal-status Critical
Priority to US19/262,540 priority patent/US20250332422A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36146—Control systems specified by the stimulation parameters
    • A61N1/3615—Intensity
    • A61N1/36153—Voltage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36125—Details of circuitry or electric components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3925—Monitoring; Protecting

Definitions

  • the present invention relates generally to implantable medical devices, and more particularly to improved compliance voltage monitoring and adjustment in an implantable pulse generator.
  • Implantable stimulation devices are devices that generate and deliver electrical stimuli to body nerves and tissues for the therapy of various biological disorders, such as pacemakers to treat cardiac arrhythmia, defibrillators to treat cardiac fibrillation, cochlear stimulators to treat deafness, retinal stimulators to treat blindness, muscle stimulators to produce coordinated limb movement, spinal cord stimulators to treat chronic pain, cortical and deep brain stimulators to treat motor and psychological disorders, and other neural stimulators to treat urinary incontinence, sleep apnea, shoulder subluxation, etc.
  • SCS Spinal Cord Stimulation
  • the present invention may find applicability in any implantable medical device system, including a Deep Brain Stimulation (DBS) system.
  • DBS Deep Brain Stimulation
  • Electrodes there are eight electrodes (Ex) on two leads 18 for a total of sixteen electrodes 16, although the number of leads and electrodes is application specific and therefore can vary.
  • the leads 18 couple to the IPG 10 using lead connectors 26, which are fixed in a non-conductive header material 28, which can comprise an epoxy for example.
  • the IPG 10 typically includes a printed circuit board (PCB) 30, along with various electronic components 32 mounted to the PCB 30, some of which are discussed subsequently.
  • PCB printed circuit board
  • Two antennas are shown in the IPG 10: a telemetry antenna 34 used to transmit/receive data to/from an external communication device (not shown); and a charging coil 36 for charging or recharging the IPG’s battery 14 using an external charger (not shown).
  • Charging coil 36 preferably comprises a coil, which receives power from an external charger by magnetic induction.
  • Telemetry antenna 34 may also comprise a magnetic-induction coil, or may alternatively comprise a short range RF antenna for wirelessly communicating in accordance with a short-range RF standard such as Bluetooth, WiFi, MICS, Zigbee, etc., as described in U.S. Patent Application Publication 2016/0051825. Telemetry antenna 34 may be located within the case 12, or may be located within the header 28 in other examples.
  • a short-range RF standard such as Bluetooth, WiFi, MICS, Zigbee, etc.
  • ASIC 60 can comprise a monolithic integrated circuit formed on its own semiconductive substrate (“chip”), and may be contained in its own package and mounted to the IPG 10’s PCB 30.
  • Figure 2 shows various functional circuit blocks within ASIC 60 in addition to the microcontroller block 150, which are briefly described.
  • ASIC 60 includes an internal bus 92, and each of the functional blocks includes interface circuitry 88 enabling communication on the internal bus 92.
  • Interface circuitry 88 helps each block recognize when microcontroller block 50 is communicating addresses pertaining to that block via bus 92.
  • ASIC 60 contains several terminals 61 (e.g., pins, bond pads, solder bumps, etc.), such as those necessary to connect to the external bus 90, the battery 14, the antennas 34 and 36, external memory (not shown), etc.
  • ASIC terminals 61 include electrode nodes 61a (EU-E16’ and Ec’) which circuit nodes are also present on the PCB 30 (Fig. 1C) inside of the IPG’s case 12.
  • the electrode nodes 61a connect to the electrodes 16 (E1-E16) on the lead(s) 18 outside of the case 12 by way of DC-blocking capacitors 55.
  • DC-blocking capacitors 55 are useful to ensure that DC current isn’t inadvertently (e.g., in the event of failure of the ASIC 60’s circuitry) injected into the patient’s tissue, and hence provide safety to the IPG 10.
  • Such DC-blocking capacitors 55 can be located on or in the IPG 10’s PCB 30. See U.S. Patent Application Publication 2015/0157861.
  • ASIC 60 may support other numbers or types of electrode nodes/electrodes (e.g., thirty-two electrodes E1-E32 plus the case Ec).
  • Telemetry block 64 couples to the IPG telemetry antenna 34, and includes transceiver circuitry for wirelessly communicating with an external device according to a telemetry protocol.
  • a telemetry protocol may comprise Frequency Shift Keying (FSK), Amplitude Shift Keying (ASK), or various short-range RF standards such as those mentioned above.
  • Charging/protection block 62 couples to the IPG charging coil 36, and contains circuitry for rectifying power wirelessly received at the charging coil 36 from an external charger (not shown), and for charging the battery 14 in a controlled fashion. See U.S. Patent Application Publication 2013/0023943.
  • Clock generation block 74 can be used to generate a clock for the ASIC 60 and communication on the bus 92.
  • Clock generation block 74 may receive an oscillating signal from an off-chip crystal oscillator 56, or may comprise other forms of clock circuitry located completely on chip, such as a ring oscillator. See U.S. Patent Application Publication 2014/0266375 (disclosing an on-chip circuit that can be used to generate a clock signal on the ASIC 60).
  • the PDAC and NDAC receive digital control signals from the registers in the stimulation circuitry block 70, generically denoted ⁇ Pstim> and ⁇ Nstim>, to generate the prescribed pulses with the prescribed timing and amplitude.
  • the PDAC and NDAC comprise current sources, but could comprise voltage sources as well.
  • a PDAC and NDAC pair may be dedicated at each of the electrodes, and thus may be activated only when its associated electrode is selected as an anode or cathode. See, e.g., USP 6,181,969.
  • the current produced by one or more PDACs or NDACs may be distributed to selected electrodes by a switch matrix (not shown).
  • Various examples of DAC circuitry 72 are disclosed in USPs 6,181,969, 8,606,362, 8,620,436, and U.S. Patent Application Publications 2018/0071520 and 2019/0083796.
  • the pulses provided at the electrodes are biphasic, meaning that each pulse comprises a first phase 94a of a first polarity, followed by a second phase 94b of an opposite polarity.
  • This is useful as a means of active recovery of charge that may build up on the DC-blocking capacitors 55.
  • the second pulse phase 94b will actively recover that charge, particularly if the total amount of charge is equal in each phase (i.e., if the area under the first and second pulse phases are equal).
  • Recovery of excess charge on the DC- blocking capacitors 55 is desirable to ensure that the DAC circuitry 72 will operate as intended: if the charge across the DC-blocking capacitors 55 is not zero at the end of each pulse, such remaining charge may impact formation of subsequent pulses, or other problems may occur, as discussed further below.
  • Passive charge recovery may therefore be employed that does not involve use of active currents driven by the DAC circuitry 72.
  • Passive charge recovery is implemented within the stimulation circuitry block 70, and includes use of passive recovery switches (e.g., transistors) 96(x), each connected between one of the electrode nodes (Ex’ and Ec’) 61a and a common reference voltage. This common reference voltage as shown may comprise the voltage, Vbat, of the battery 14 as (Fig.
  • variable resistor 97 can be connected in series to each of the passive recovery switches 96 between the electrodes nodes 61a and the common reference voltage (e.g., Vbat) to set the rate of passive discharge during periods 98. See U.S. Patent Application Publication 2018/0071527 (discussing passive charge recovery).
  • a method for programming a stimulator device comprising a plurality of electrodes and current generation circuitry configured to provide pulses at selected ones of the electrodes, wherein the current generation circuitry is powered by a time-varying compliance voltage produced at an output of a compliance voltage generator.
  • the method may comprise: receiving information defining a waveform comprising a sequence of pulses; determining a plurality of groups of one or more contiguous pulses in the waveform; associating each group with a compliance voltage variable; and determining programming instructions configured to: program the current generation circuitry to produce the groups thereby producing the waveform at the selected ones of the electrodes, and program the compliance voltage generator to produce the time-varying compliance voltage at the output, wherein the compliance voltage generator is programmed with the compliance voltage variable associated with the group being produced by the current generation circuitry.
  • the method further comprises determining a compliance voltage value for each compliance voltage variable.
  • the compliance voltage values are determined by taking measurements in the stimulator device.
  • each compliance voltage value is determined to be suitable to produce the pulses in their associated group at prescribed amplitudes.
  • each compliance voltage value is further determined to preserve power in the stimulator device.
  • the method further comprises use of an external device in communication with the stimulator device, wherein the information defining the waveform is received at the external device, wherein each group is associated with a compliance voltage variable at the external device, and wherein the programming instructions are determined at the external device; and further comprising transmitting the programming instructions from the external device to the stimulator device.
  • the computer-implementable algorithm is configured to automatically determine the one or more contiguous pulses in each group by applying one or more rules that identify that at least some of the one or more contiguous pulses have similar compliance voltage requirements.
  • the one or more rules identify that the one or more contiguous pulses have amplitudes that are within a specified range.
  • the one or more rules identify that the one or more contiguous pulses have energies that are within a specified range.
  • the method further comprises use of an external device in communication with the stimulator device, wherein at least one of the plurality of groups is determined at least in part based on input received from a user at the external device.
  • the first compliance voltage variable is lower than a preceding compliance voltage variable, wherein the time-varying compliance voltage falls over the first time period, and wherein the time-varying compliance voltage equals the first determined compliance voltage during the second time period.
  • an amplitude or energy of the pulses in the first group is constant during the first and second time periods.
  • the time-varying compliance voltage rises or falls over time periods when the compliance voltage variables to which the compliance voltage generator is programmed change.
  • the time periods are used to determine the plurality of groups.
  • the compliance voltage variables are determined such that the time- varying compliance voltage is always high enough to form the sequence of pulses in the waveform at prescribed amplitudes.
  • the time period before each transition is determined to allow the time- varying compliance voltage to increase such that compliance voltage will be at a value suitable to form pulses after the first transitions at prescribed amplitudes.
  • the time period before each transition is determined by determining a rise time at the output of the compliance voltage generator at each first transition.
  • the rise times are measured at each first transition.
  • the programming instructions are further configured to program the stimulator device to make measurements to assess the time-varying compliance voltage.
  • the measurements are made during at least one of the pulses after each of the first transitions.
  • the stimulator device is configured to adjust programming of the compliance voltage generator using the measurements.
  • the compliance voltage generator is programmed to respectively further increase, or lower while still increasing, the time-varying compliance voltage at the first time before that first transition.
  • the compliance voltage generator is programmed at the first times with values, and wherein if the stimulator device determines during a given measurement associated with one of the first transitions that the time-varying compliance voltage is too low, or too high, the compliance voltage generator is programmed to respectively increase, or decrease, the value at the first time before that first transition.
  • each compliance voltage is determined to be suitable to produce the pulses in its associated group of pulses at prescribed amplitudes. In one example, each compliance voltage is further determined to preserve power in the stimulator device. In one example, the method further comprises use of an external device in communication with the stimulator device, wherein each compliance voltage is determined at the external device. In one example, at least one of the compliance voltages is determined based on input received from a user at the external device. In one example, each compliance voltage is determined using compliance voltage measurements taken at the stimulator device, and further comprising transmitting the determined compliance voltages to the external device. In one example, each compliance voltage is determined at the stimulator device.
  • the method may comprise: receiving information defining a waveform comprising a sequence of pulses, each of the pulses formed in accordance with stimulation parameters; determining at least one group of one or more contiguous pulses in the waveform, wherein the at least one group comprises a plurality of contiguous blocks of pulses, wherein the stimulation parameters vary between each of blocks, wherein each at least one group is associated with a compliance voltage variable; executing a computer-implementable algorithm to automatically determine one or more first of the plurality of contiguous blocks in each at least one group that will be used to determine the compliance voltage variable for each group; and automatically determining programming instructions configured to: program the current generation circuitry to produce the at least one group thereby producing the waveform at the selected ones of the electrodes, program the compliance voltage generator with the compliance voltage variable associated with the at least one group being produced by the current generation circuitry, and cause the stimulation device to make measurements to assess the compliance voltage during at least one pulse in each of the one or more first blocks in each group.
  • the pulses in each group are each provided to a first of the plurality of electrodes. In one example, the pulses in each group are each provided to the first electrodes with a same polarity and a same amplitude percentage. In one example, the method further comprises determining a compliance voltage value for each compliance voltage variable using the measurements. In one example, each compliance voltage value is determined to be suitable to produce the pulses in their associated group at prescribed amplitudes. In one example, each compliance voltage value is further determined to preserve power in the stimulator device. In one example, if the measurements indicate during production of one of the at least one groups that the compliance voltage is too low, the stimulator device is configured to adjust the compliance voltage variable associated with that group to a higher value.
  • the method further comprises determining a compliance voltage value for each compliance voltage variable at the external device, wherein the programming instructions are configured to program the compliance voltage generator with the compliance voltage values to produce the compliance voltage at the output. In one example, the method further comprises determining a compliance voltage value for each compliance voltage variable at the stimulator device using the measurements, and transmitting the determined compliance voltages values to the external device. In one example, the programming instructions are configured to program the compliance voltage generator with the compliance voltage values to produce the compliance voltage at the output, wherein the compliance voltage generator is programmed with the compliance voltage value associated with the at least one group being produced by the current generation circuitry. In one example, at least one of the at least one groups is determined at least in part based on input received from a user at the external device.
  • the information defining the waveform is received at the stimulator device, wherein each at least one group is determined at the stimulator device, wherein the computer-implementable algorithm is executed at the stimulator device, and wherein the programming instructions are determined at the external device.
  • the method further comprises determining a compliance voltage value for each compliance voltage variable at the stimulator device using the measurements.
  • the computer-implementable algorithm is used to determine the at least one group of one or more contiguous pulses in the waveform.
  • the one or more first blocks in each at least one group comprise the blocks with the highest-energy pulses in that group.
  • the one or more first blocks in each at least one group comprise the blocks with the highest-amplitude pulses in that group.
  • the one or more first blocks in each at least one group comprise the blocks with the highest-pulse width pulses in that group. In one example, the one or more first blocks in each at least one group comprise a block with the highest-amplitude pulses in that group and a block with the highest-pulse width pulses in that group. In one example, the one or more first blocks in each at least one group comprise a block with pulses having a first amplitude and a first pulse width, and a block with pulses having a first amplitude and a first pulse width, wherein the first amplitude is higher than the second amplitude, and wherein the first pulse width is lower than the second pulse width.
  • the one or more first blocks in each at least one group comprise a block applied to a first of the plurality of electrodes, and a block applied to a second the plurality of electrodes.
  • the programming instructions are configured to cause the stimulation device to make measurements to assess the compliance voltage during at least a first pulse in each of the one or more first blocks in each group.
  • FIGS 1A-1C show an Implantable Pulse Generator (IPG), and the manner in which an electrode array is coupled to the IPG, in accordance with the prior art.
  • IPG Implantable Pulse Generator
  • Figure 2 shows an architecture for an IPG utilizing at least one Application Specific Integrated Circuit (ASIC).
  • ASIC Application Specific Integrated Circuit
  • FIG. 3 shows aspects of the Digital-to-Analog Converters (DACs) within the stimulation circuitry of the ASIC, and stimulation pulses formable thereby.
  • DACs Digital-to-Analog Converters
  • Figures 4A-4C show further details of the stimulation circuitry and DAC circuitry.
  • Figure 5A shows a waveform issued according to an aggregate program (Fig. 5C) that references a pulse program and a steering program (Fig. 5B).
  • Figure 6 shows external devices useable to program the IPG, and which may execute a compliance voltage (VH) management algorithm.
  • Figures 7A-7D show examples of a graphical user interface (GUI) that can be executed on an external device to allow a user to form a complex waveform using different blocks of pulses, and shows the compilation of programming instructions for the IPG necessary to form the waveform at the IPG, including the compilation of aggregate, steering, and pulses programs.
  • GUI graphical user interface
  • Figures 8A and 8B show how a compliance measurement instruction (e.g., a CMB) can be included in the IPG’s programming instructions, and further shows measurement circuitry responsive to the instruction, which culminates in determining a value VH(opt) used to program a compliance voltage generator that set a value for the compliance voltage VH received by the DAC circuitry.
  • a compliance measurement instruction e.g., a CMB
  • VH(opt) used to program a compliance voltage generator that set a value for the compliance voltage VH received by the DAC circuitry.
  • Figures 9A and 9B show circuitry for the compliance voltage generator, which in this example comprises a capacitor-based charge pump.
  • Figures 10A and 10B show examples of manners in which capacitors in the compliance voltage generator can be connected to derive a compliance VH with a particular gain value.
  • Figure 11A shows the example complex waveform of Figure 7A, and shows that while compliance measurement instructions can be used to automatically adjust the compliance voltage VH, VH can still be too low to adequately form some of the pulses of higher amplitudes.
  • Figure 1 IB shows a table defining relevant aspects of the waveform, which table can be adjusted in subsequent steps of a VH management algorithm.
  • Figures 13A-13D show steps in the algorithm for determining groups of pulses in the waveform, where pulses in such groups will be treated similarly by the algorithm for compliance voltage management purposes.
  • Figure 14A shows steps in the algorithm for determining optimal compliance voltages VH(opt) for each of the determined groups
  • Figure 14B shows steps in the algorithm for determining rise times and fall times of VH at transitions between the groups of pulses.
  • the result from Figures 14A and 14B are illustrated in the updated table of Figure 14C.
  • Figures 15A-15C show steps in the algorithm for identifying groups for which compliance voltage management is not practical, and thus consolidating such identified groups into preceding or following groups.
  • Figure 19 shows VH as actually produced for the waveform using the programming instructions determined by the algorithm, and shows that VH is not too low, and is only minimally too high.
  • Figures 20A-20E shows how the algorithm can include compliance voltage measurement instructions in the IPG’s programming instructions as useful to updating the determined optimal values for VH.
  • Figure 22 shows that compliance voltage measurements can be used to determine optimal values for VH, and therefore such values do not need to be specifically determined by the algorithm in advance of waveform execution in the IPG.
  • Figures 23A-23E shows different examples of how the algorithm can group blocks of pulses, and decide when compliance voltage measurement should be made within each group.
  • the total anodic and cathodic current is 3.0 mA
  • ⁇ A> is thus digitally set to indicate this value; for example, and assuming ⁇ A> increments in 0.1 mA steps, ⁇ A> can be set at time tO to 30, or 0011110 in binary.
  • Electrodes El and E2 split the anodic current equally, and so Xpl and Xp2 are set at time tO to 50%, or 0110010 in binary.
  • Electrode E3 receives all of cathodic current, and so Xn3 is set at time tO to 100%, or 1100100 in binary.
  • Figure 4B shows an example of the circuitry of an NDAC (e.g., NDAC1) for providing a cathodic current at an electrode node (e.g., El’).
  • NDAC an NDAC
  • El an electrode node
  • Other NDACs would be similar.
  • the PDACs as shown in the ‘796 Publication, also have similar circuitry, although of opposite polarity due to the anodic currents the PDACs produce.
  • the passive charge recovery switch 96(1) connected to electrode node EG, which was explained earlier with respect to Figure 3.
  • Amplified reference current A*Iref_n (shortened to A*Iref in Figure 4B) is provided from the distributor 102 to one or more resistance transistors 110 through an always-on switch 112.
  • the NDAC also includes a number of branches (e.g., 100 branches), with each branch having a branch transistor 114_x connected in series to a switch 116_x.
  • a reference voltage Vref is maintained across the resistance transistor(s) 110 (at node 122) and each of the branches (at node 124).
  • the resistance of switches 112 and 116_x are negligible, and so Vref is effectively dropped across the resistance transistor(s) 110 and each of the branch transistors 114_x.
  • Resistance transistor(s) 110 and branch transistors 114_x are not connected in a current mirror configuration, but are on to the same degree due to their common gate connection at node 126. These transistors 110 and 114 are preferably of different widths W1 and W2, with W2 larger than Wl, meaning that the resistance of the branch transistors 114 are W2/W1 less than the resistance of the resistance transistor(s) 110. This resistance difference, coupled with the common voltage drop Vref across each, sets the current in each branch, again as explained in detail in the ‘796 Publication.
  • Stimulation circuitry 70 as shown in Figure 4C shows further details of how relevant control signals such as ⁇ A> and ⁇ X> arrive at the DAC circuitry 72.
  • the stimulation circuitry 70 includes memory circuitry that stores microcode processed by one or more pulse definition circuits (PDCs) 140.
  • Memory circuitry includes a steering memory 142 that contains electrode steering programs, and a pulse memory 144 that contains pulse programs, both of which are discussed further with respect to Figure 5B.
  • Memory circuitry also includes an aggregate memory 146 that contains aggregate programs that link or associate one or more pulse programs and one or more steering programs to create a desired stimulation pulse therapy program, as discussed further with respect to Figure 5C.
  • the stimulation circuitry 70 additionally includes a configuration memory 148 that stores configuration parameters, some of which are global and applied across all PDCs 140, and some of which are specific to a particular PDC 140.
  • the memories 142-148 can be read from and written to by the microcontroller 50 via bus 92.
  • Each location (e.g., each 32-bit location) in the memory circuitry may be formed as a register of multiple flip-flops or as an addressable location in a more typical memory, and may comprise separate memory circuits or a single memory circuit.
  • an electrode combiner 150 is used to reconcile information concerning what the total anodic and cathodic current amplitude A, and what percentage control switches ⁇ X> (and hence which switches 116 in the DACs), should be asserted at any given time.
  • the electrode combiner 150 can receive amplitude and percentage information from each PDC 140 (e.g., ⁇ Aa>, and ⁇ Xpla>, ⁇ Xnla>, ⁇ Xp2a>, etc. from PDC 140a, and ⁇ Ab>, and ⁇ Xplb>, ⁇ Xnlb>, ⁇ Xp2b>, etc.
  • FIG. 5 A shows an example of a waveform that can be produced in a particular timing channel (e.g., TCa, using PDAC 140a).
  • a particular timing channel e.g., TCa, using PDAC 140a.
  • two electrodes El and E2 have been selected for stimulation, which occurs by selection of a particular steering program A in steering memory 142, as shown in Figure 5B.
  • a steering program generally informs as to which electrodes are to receive pulses, the polarity of the pulses at those electrodes, and a percentage of the total anodic and cathodic amplitude for the pulses at those electrodes.
  • Electrodes E3 and E4 which are not used in this example, receive 0% of the total current, making their polarities irrelevant, and the same would be true for the remaining electrodes in subsequent memory locations (e.g., next memory location Y+l storing data for electrodes E5-E8 would also have 0%, etc.).
  • pulse program B defines a biphasic pulse having six phases, as shown in Figure 5B’s waveform.
  • the first phase (memory location X) comprises an actively-driven pre-pulse phase, which may be of low amplitude A1 and a short duration Dl. It is designated as an active-driven recovery phase (AR), which operates to flip the polarity of the electrodes otherwise specified by the steering program.
  • AR active-driven recovery phase
  • pulse program B is associated with steering program A
  • El would comprise a cathode and E2 an anode during this pulse phase, as shown in the waveforms.
  • a pulse program may comprise a number of successive stimulation phases (S) of increasing amplitudes, which would create a pulse with a rising stair-stepped shape.
  • S successive stimulation phases
  • Any pulse program in memory 144 may be associated with any steering program in memory 142 to create pulses defined by the pulse program at the electrodes defined in the steering program, and this occurs by use of an aggregate program stored in aggregate memory 146, as shown in Figure 5C.
  • the external device 160 can include control circuitry 166.
  • control circuitry 166 may include a microprocessor, microcontroller, microcomputer, FPGA, DSP, or other digital logic structures capable of executing programs in a computing device.
  • control circuitry 166 may comprise any of the types of i5 processors sold by Intel Corp., see https://www.intel.com/ content/ www/us/en/products/ processors/core/i5-processors.html.
  • the control circuitry 166 is capable of executing external device software 164 programmed into the external device 160.
  • External device software 164 can comprise instructions stored in a non-transitory computer-readable medium in the external device 160, such as in memory associated with or readable by the control circuitry 166. Such memory can comprise solid state, magnetic, or optical memories, or other types of non- transitory memory devices. External device software 164 may also be present on non- transitory computer readable media that exist outside of the external device 160 (e.g., on disks in a server, on a memory stick, etc.), which can then later be loaded into in the external device’s memory.
  • this panel can reflect the selected electrodes (e.g., El as anode and E2 as cathode from steering program A), and reflect other important parameters, such as the (maximum) amplitude of the pulses, their frequency (e.g., 100 Hz), and the overall pulse period (e.g., 10 ms), which can be derived from the relevant pulse program for the block in question.
  • Information concerning individual pulse phases e.g., their amplitudes and durations
  • Each of the block panels 192 also allows a user to specify a number of pulses that appear within each block.
  • block 1 comprises 10 pulses (of the pulses specified by pulse program I);
  • block 2 comprises 20 pulses (of pulse program J);
  • block 3 comprises 5 pulses (of pulse program K);
  • blocks 4, 5, and 6 comprises 10 pulses (of pulse programs J, I and J respectively).
  • blocks 7-11 comprise 10, 10, 10, 3, and 10 pulses respectively (of pulse programs I, L, M, N, and I respectively).
  • Each of the block panels 192 preferably also displays an optimal compliance voltage variable, VH(opt), to program the VH generator 76 during each block. How VH(opt) can be automatically be determined for each block, and how different blocks can be grouped and automatically assigned a single VH(opt) for the group, are discussed further below. However, note that the user or clinician can also use the block panels 192 in GUI 170 to manually enter VH(opt) for a particular block (or group).
  • Figure 7B shows another example (using blocks 1-6 only) in which the simulation waveform 299 of Figure 7A can be defined by using different amplitude scaling factors in each of the blocks.
  • each of the blocks 1-6 are defined using only pulse program K, which specifies a maximum amplitude of 6 mA.
  • the amplitude scaling factor is then adjusted in each block panel 192 to set the amplitude of the pulses in the blocks.
  • biphasic pulses of amplitude A are provided between electrodes El and E2 (as dictated by a steering program A). These pulses may comprise an aggregate instruction in a larger aggregate program 1, and may comprise pulses within a particular block as discussed earlier with reference to Figures 7A-7D.
  • the circuitry shows operation during stimulation phase 94a of the biphasic pulse, and thus shows PDAC1 activated to provide an anodic current of amplitude +A to El, and shows NDAC2 activated to provide a cathodic current of amplitude -A to E2. Note that during active charge recovery phase 94b (when the polarity of the current is reversed), PDAC2 and NDAC1 would be activated, although this isn’t shown.
  • FIG. 8A explains how the stimulation circuitry 70 in the IPG 10 can be programmed to dictate when compliance voltage measurements are taken.
  • a compliance monitoring instruction is included within the pulse program E that is used to form the pulses.
  • Such an instruction in this example comprises a compliance monitoring bit (CMB; bit 17), which can be set during any of the phases of the pulse, e.g., in any of the memory locations X, X+l, etc. describing such phases.
  • the CMB instructs the compliance detector circuitry 200 to measure and process the voltages at the electrode nodes involved in providing stimulation (e.g., VE1 and VE2) during pulse phases in which the CMB is set.
  • the timing of the compliance voltage measurement can be set in different ways, and could be prescribed in pulse program E along with the CMB.
  • compliance measurement timing is set using the stimulation circuitry 170’s configuration memory 148 (Fig. 4C).
  • this memory 148 can include a compliance monitor timing register 149, which defines when the compliance monitoring bit instruction will issue during the duration of the pulse phase in which it is set. Such timing may be defined in a number of ways.
  • a cathode electrode node voltage e.g., VE2H
  • Vn2H ‘1’
  • VplH anode high signal
  • the reference voltages received by the window comparators are formed by a window reference voltage generator 202.
  • Generator 202 comprises an op amp 204, which receives a reference voltage, such as a IV, and which outputs to a transistor 206.
  • An upper resistance Rp is connected between the compliance voltage VH and one terminal of the transistor 206, and a lower resistance Rn is connected between ground and the other terminal the transistor 206.
  • the upper and lower resistances Rp and Rn comprise a number of taps 203, which taps can be selected to adjust the reference voltages Vp(ref)H and Vp(ref)L used by the window comparators 208p, and to adjust the reference voltages Vn(ref)H and Vn(ref)L used by the window comparators 208p.
  • Vn2H is asserted, meaning that Vn dropped across NDAC2 is too high. This might warrant (depending on the particulars of compliance logic 220) reducing the compliance voltage VH to save power. If VE2 is lower than 0.4V, Vn2L is asserted, meaning that the Vn drop is too low. This might warrant (again, depending on compliance logic 220) increasing the compliance voltage to ensure that pulses are formed with their prescribed amplitudes. Similarly, if VE1 from anode electrode El is lower than VH - 0.7V, VplH is asserted, meaning that Vp dropped across PDAC1 is too high.
  • Control circuitry 50 in turn, through its own programming, can control the VH generator 76 (Fig. 3) to either increase or decrease the value of VH by asserting a new value for VH(opt), as explained further with respect to Figures 9A and 9B.
  • VH measure algorithms 222 and related circuitry operable in compliance logic 220 are discussed further in the ‘512 Publication, and are not reiterated here. Note that compliance logic 220 may be considered to comprise part of control logic 50.
  • the VH generator 76 essentially comprises a DC-DC voltage converter, and outputs a compliance voltage VH as boosted from an another power supply available in the IPG 100, such as the voltage of the IPG 10’s battery 14 (Vbat).
  • VH generator 76 can for example, comprise an inductor-based boost converter (see, e.g., U.S. Patent Application Publication 2015/0134029).
  • VH generator 76 can also comprise a capacitor-based charge pump, again described in the ‘512 Publication (see also USPs 8,219,196; 9,233,254; 7,805,189).
  • a charge pump implementation is described in detail here with respect to Figures 9A-10B, but again other VH generator circuits could be used as well.
  • FIG. 9B shows information in the VH gain table 232 that is used by switching network control 230.
  • Vbat battery voltage
  • Table 232 also shows the various values of the switching control signals ⁇ S> needed to achieve the desired gain during the first and second phases f ⁇ and f2.
  • switching control signals ⁇ S3_1> are provided from the switching network control 230 to the switching network 234 during the first phase f ⁇ , and switching control signals ⁇ S3_2> are provided during the second phase f2.
  • the particulars of the switch control signals ⁇ S> can vary in different implementations, and more or fewer gain values could be used and included in table 232. In large part, the switching control signals ⁇ S> depend on the number of gains the system will support, the particulars of the switching network 234, and the number of capacitors 240 used.
  • Figures 10A and 10B shows examples of how the switching control signals ⁇ S> control the switching network 234 to connect the various plates of the capacitors 240 for achieve different gain values.
  • the top of Figure 10A shows a simple example, in which VH simply equals Vbat for a gain of 1.
  • VH simply equals Vbat for a gain of 1.
  • the first plates 1 of the capacitors are connected to Vbat, and the second plates 2 of the capacitors are connected to ground, thus connecting the capacitors in parallel, and charging each capacitor to Vbat.
  • this connectivity doesn’t change, except now the first plates 1 of the capacitors are connected to output VH, which will equal Vbat.
  • the first and second phases f ⁇ and f2 are run continually, with f ⁇ followed by f2 followed by f ⁇ and so on.
  • VH is set equal to 1.5*Vbat, or again of 1.5.
  • capacitors Ca and Cb are connected in series, and Cc and Cd are connected in series, with these series connections connected in parallel between Vbat and ground. This charges each of the capacitors to l/2Vbat.
  • the capacitors are connected with Cc in parallel with Cd, and with this parallel connection in series with Cb and Ca. Cc and Cd were previously charged (f ⁇ ) to l/2Vbat, so their parallel connection also results in l/2Vbat.
  • Figure 11 A returns to the example waveform 299 that was described in Figure 7 A, which includes blocks of pulses with different amplitudes formed in accordance with pulse programs I (4 mA), J (2 mA), and K (6 mA), L (3.8 mA), M (4.2 mA), andN (1.0 mA).
  • Figure 11B shows a table 313 depicting relevant information for the waveform 299 and for each of the blocks.
  • Table 313 may be generated by the external device 160 and its software 164 (Fig. 6) once the user has defined waveform 299.
  • Table 313 can include the duration of the blocks, the number of pulses in each block, and a pulse program for each block, which, among other details, prescribes the amplitude of the pulses in each block.
  • the information in table 313 can be tracked and updated using a VH management algorithm 250, as explained subsequently.
  • algorithm 250 can operate in whole or in part in the IPG 10, and optional next step 300 contemplates usage of the algorithm 250 in the IPG 10, which can be implemented by programming algorithm 250 into the IPG’s control circuitry 50.
  • information defining the waveform 299 e.g., IPG programming information such as the pulse, steering, and aggregate programs described earlier (Fig. 7C) — are compiled at the external device 160 and transmitted to the IPG 10.
  • Algorithm 250 in the IPG 10 can then analyze the waveform information, and take steps as subsequently described to allow the IPG 10 to manage VH.
  • the relevant block durations are added to arrive at the group duration.
  • group duration for group 7 comprises 300 ms, because its blocks 7, 8, and 9 each have block durations of 100 ms.
  • Table 313 can be defined and stored in the control circuitry 166 of the external device 160 or the control circuitry 50 of the IPG 10, depending on where algrohtm 250 is implemented, and table 313 can continue to be updated as shown in later steps.
  • fall times tfl_2 and tf5_6 occur when transitioning between the same VH(opt) levels (from 7.5V to 6.0V), and so this measurement (40 ms) needs only to be made once.
  • Measuring VH Gx for each of the groups (309), and measuring rise and fall times (317), may also occur using a single test waveform. However, the use of different test waveforms 314 and 319, applied to each group or transition, is illustrated for discreteness and simplicity.
  • an identified group in step 320 may not be associated with a following rise time. Although not illustrated, this would occur for a group (20) that is preceded by a group (19) of higher amplitude pulses, and is followed by a group (21) of lower amplitude pulses.
  • group 20 is associated with a fall time tfl9_20 from group 19, but is associated with another fall time tf20_21 (not a rise time) going into group 21.
  • the rise time tr for such a group would thus be 0 in step 325.
  • step 325 effectively inquires whether the preceding tfl9_20 is greater than the group duration of group 20, meaning that VH(opt) for group 20 could never be reached. If this case, group 20 would be consolidated into group 19 (step 327).
  • Rise time tr6_7 30 ms already covers a discrete number of pulses (again three), and so group 6b’s duration is likewise set to 30 ms. Some margin may also be added to these group durations. For example, the duration of group 2b could be set to values higher than 50 ms, and thus would cover more pulses than is actually required for VH to ramp upwards.
  • VH management algorithm 250 may be necessary for the VH management algorithm 250 to define new pulse programs at this point so that CMB can be properly set when desired.
  • CMB is set during aggregate instructions Z+6 and Z+9, which references pulse program I to form blocks 5 and 7.
  • Aggregate instructions Z and Z+13 also reference aggregate program I to form blocks 1 and 11, but it is not necessary to CBM in these instructions.
  • the algorithm 250 may therefore create two versions of this pulse program: I to be used during blocks 5 and 7 in which CMB is not set, and G to be used during blocks 1 and 11 in which CMB is not set, as shown in the aggregate program of Figure 20B.
  • CMB is also set during aggregate instruction Z+3, which references pulse program K, and during aggregate instructions Z+l 1, which references pulse program M. Because these pulses programs K and M aren’t referenced in any other instructions (and in particular are not referenced in instructions where CMB should not be set), CMB can simply be set in these pulses programs without the need to compile additional pulses programs K’ and M’.
  • IPG programming instructions are complete and include the necessary information to the IPG 10 to produce the waveform 299 (the aggregate program, and the pulse and steering programs it references), to adjust VH when needed (e.g., by setting INT(VH_adj) and compiling VH(opt) table 360), and to measure VH (e.g., by setting CMB in relevant pulses programs and aggregate instructions). Assuming that VH management algorithm 250 has been operating in the external device 160, such programming instructions can then be transmitted to the IPG 10 in step 363 for storage and execution.
  • CBM is set in all of the pulses programs referenced in the various aggregate instructions, as shown in Figure 21B.
  • the compliance logic 220 can be independently programmed to always measure the compliance voltage on every pulse as an operation mode selection, without the need to specify such measurements in the IPG’s programming instructions.
  • a VH adjust algorithm 223 (Fig. 21 C) is compiled or enabled.
  • the VH adjust algorithm 223 can operate in the IPG’s control circuitry 50, and functions to consider only relevant ones of the compliance voltage measurements, i.e., to consider INT(VH meas) only for certain pulses.
  • the VH adjust algorithm 223 will only consider certain of those measurements.
  • the VH adjust algorithm 233 dictates the timing of when compliance voltage measurements are made.
  • VH adjust algorithm 223 and its associated rules 380 can be compiled by the VH algorithm 250, or the VH management algorithm 250 can enable the use of the VH adjustment algorithm 223 in the IPG if it has already determined.
  • the algorithm 250 may not be able to readily determine a single block within a compliance voltage group that should be measured and used to govern the compliance voltage for that block, as illustrated in Figure 23B.
  • a compliance voltage group is defined having five blocks. Blocks 1, 2, and 4 have pulse widths of 40 microseconds, and for these blocks the algorithm 250 can conclude that block 2 would be a worst case because the pulses in this block have the highest amplitude (energy) (4.0 mA).
  • Blocks 3 and 5 by contrast have pulse widths of 60 microseconds, and for these blocks the algorithm 250 can conclude that block 3 would be a worst case because the pulses in this block have the highest amplitude (energy) (3.0 mA).
  • compliance voltage group 2 depending on the algorithm 250’ s programming, could be consolidated into group 1 despite the difference in steering programs used within this consolidated group.
  • block 4 is of short duration, and/or contains pulses of significantly low energies, such consolidation could be logical despite the difference in steering programs used.
  • the user may simply decide unilaterally use GUI 170 to consolidate certain pulses into a common compliance voltage group (see, e.g., Fig. 13C) despite the difference in steering programs.

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Abstract

La présente invention concerne un algorithme de gestion de tension de conformité permettant de gérer la tension de conformité, VH, qui alimente le circuit CNA dans un dispositif de stimulation. Un utilisateur peut utiliser une interface utilisateur associée à un dispositif de programmation externe pour définir une forme d'onde de stimulation variant dans le temps à programmer dans le dispositif de stimulation. L'algorithme analyse la forme d'onde prescrite et détermine un nombre de groupes d'impulsions qui seront traités de manière similaire dans l'optique de la gestion de VH. Des tensions de conformité optimales sont déterminées pour chaque groupe, ainsi que les vitesses de montée et de chute auxquelles la VH peut changer à des transitions entre des groupes. Ces vitesses de montée ou de chute de VH sont ensuite utilisées pour définir à quel moment la tension de conformité devrait augmenter ou diminuer. Par exemple, l'algorithme définit automatiquement que la VH commence à s'élever avant une transition de telle sorte qu'elle se trouve à la valeur supérieure appropriée lorsque la transition se produit.
PCT/US2020/049054 2019-09-06 2020-09-02 Gestion de tension de conformité pour un dispositif de stimulation Ceased WO2021046120A1 (fr)

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US17/753,135 US12383745B2 (en) 2019-09-06 2020-09-02 Management of compliance voltage for a stimulator device
AU2020340952A AU2020340952B2 (en) 2019-09-06 2020-09-02 Management of compliance voltage for a stimulator device
US19/262,540 US20250332422A1 (en) 2019-09-06 2025-07-08 Management of Compliance Voltage for a Stimulator Device

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